A Multicenter, Randomized, Double-Masked Study To Compare The Ocular Safety, Tolerability, And Efficacy Of A Topical 0.2% Ophthalmic Corticosteroid Solution (SURF-201) To Vehicle In Cataract Surgery Subjects

Surface Ophthalmics, Inc.10 sites in 1 country91 target enrollmentMarch 3, 2020

ConditionsPost-surgical Ocular Inflammation Post-surgical Ocular Pain

InterventionsSURF-201 Placebo

DrugsSURF-201 Placebo

Overview

Phase: Phase 2
Intervention: SURF-201
Conditions: Post-surgical Ocular Inflammation
Sponsor: Surface Ophthalmics, Inc.
Enrollment: 91
Locations: 10
Primary Endpoint: Anterior Chamber Cell (ACC) Grade: Number of Participants Achieving an ACC Grade of 0
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

SURF-201 is being studied for the treatment of eye inflammation and pain in people who are undergoing cataract surgery. SURF-201 is an investigational drug (which means the study drug is currently being tested) in the form of a sterile eye drop.

The purpose of this research study is to see how well SURF-201 works and what side effects there are, and to compare it with Vehicle (placebo). This study will involve about 80 study participants at several different research sites in the United States.

Registry

clinicaltrials.gov

Start Date

March 3, 2020

End Date

November 20, 2020

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Surface Ophthalmics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult subjects age 18 years or older scheduled for uncomplicated unilateral cataract surgery with posterior chamber intraocular lens (IOL) implantation.
•Subjects must be able to understand and sign the Informed Consent Form (ICF).
•Female subjects of childbearing potential must agree to and submit a negative urine pregnancy test before any study-specific procedures are performed. The subjects must be using and continue to use a suitable method of contraception for the duration of the study: spermicide with barrier, oral contraceptive, transdermal contraceptive, injectable or implantable contraceptive, intrauterine device (IUD), abstinence or surgical sterilization of a partner. If a subject is not of childbearing potential (e.g., has been postmenopausal for at least 12 months or is premenarchal, or has undergone a hysterectomy, bilateral oophorectomy or a bilateral tubal ligation), a urine pregnancy test and use of a suitable method of contraception for the duration of the study will not be required.
•Subjects must have a best-corrected visual acuity (BCVA) of at least +1.0 log of the minimum angle of resolution (logMAR) (Snellen equivalent of 20/200) in the non-study eye (fellow eye).
•Subjects must have an intraocular pressure (IOP) of \>8 mmHg and ≤22 mmHg in the study eye (surgery eye).
•Subject must agree to maintain their current dosing regimen throughout the study period (from Screening through Day 32) if they are currently using topical cyclosporin-A or Xiidra (lifitegrast 5%).
•Subjects must be willing and able to attend all study visits and follow all instructions.
•Subjects must be able to self-instill the study drug (if unable, a caregiver must be available to instill all doses of the study drug).
•Subjects must agree to avoid any medications which are disallowed (as defined by the protocol).

Exclusion Criteria

•Subject has any intraocular inflammation (cells and flare in the anterior chamber) or ocular pain (pain score of \>0) in either eye prior to surgery.
•Subject has any extraocular inflammation in the study eye prior to surgery (blepharitis is allowed if only scurf is present without any concurrent conjunctivitis or lid erythema/edema) or ongoing uveitis.
•Subject has a history of diabetic retinopathy and/or previous vitrectomy in the study eye within the last 2 years prior to Screening which, in the investigator's opinion, is clinically significant and could impact the normal outcome of an uncomplicated cataract surgery.
•Subject has a diagnosis of severe dry eye in the study eye.
•Subject has any sign of iritis or scleritis in the study eye.
•Subject has a history of glaucoma surgery in the study eye within the last 2 years prior to Screening.
•Subject has a history of retinal surgery in the study eye within the last 2 years or plans to undergo retinal surgery in the study eye during the study period (from Screening through Day 32)
•Subject has a history of Fuchs' dystrophy in the study eye.
•Subject has guttata or chalazion in the study eye.
•Subject has undergone radial keratotomy, photorefractive keratotomy, advanced surface ablation, corneal transplant, or LASIK in the study eye within the last 2 years prior to Screening.

Arms & Interventions

SURF-201

0.2% topical preservative-free corticosteroid solution (0.2% betamethasone sodium phosphate)

Intervention: SURF-201

Vehicle

Topical preservative-free vehicle (Placebo)

Intervention: Placebo

Outcomes

Primary Outcomes

Anterior Chamber Cell (ACC) Grade: Number of Participants Achieving an ACC Grade of 0

Time Frame: Day 15

The Investigator used a slit lamp biomicroscope to assess ACCs in the study (surgery) eye. ACC counts were graded as follows: ACC Grade 0 = 0 cells were seen ACC Grade higher than 0 = 1 or more cells were seen